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All Target Vessel MI were NQWMI for both the SYNERGY and PROMUS Element Stents

*One NQWMI in the SYNERGY group was periprocedural. The remaining 2 NQWMI in the SYNERGY arm were considered unrelated to the study device: one at day 347 due to anemia and a major GI bleed, and one at day 364 subsequent to respiratory failure in a patient with severe COPD – enzymes were checked indicating that a NQWMI had occurred. The one death was of an unknown cause at day 472 and adjudicated as a Cardiac Death. Safety Population. All p-values are >0.05.

EVOLVE Trial

EVOLVE II Diabetes Substudy

* Spontaneous MI was defined as the rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the upper reference limit (URL) with ≥1 of the following: symptoms of ischemia, ECG changes, and or evidence of loss of myocardium. Peri-PCI MI was defined by any of the following: i) CK-MB >3X URL within 48 hours, ii) new pathological Q waves, iii) autopsy evidence. All ST were definite.

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